FDA Issues New Guidance for Industry On New Chemical Entity Exclusivity
By Cyndi Root
The Food and Drug Administration (FDA) has issued procedural draft guidance on new chemical entity (NCE) exclusivity for some fixed-combination drug products. The FDA has maintained that these products can only receive five years of exclusivity if all of the ingredients are new. If one drug in the combination has been previously approved, the combo is not eligible for five years exclusivity. The federal agency has received numerous complaints regarding this long-standing system. In response, the FDA has admitted that the complaints have merit and deserve a hearing in the public interest.
Current System
The FDA’s current approach is an interpretation of statutes and regulatory provisions including the 5-year NCE exclusivity provision. Section 505(b) of the FD&C Act (21 U.S.C. 355(b)) articulates the procedure for new drug applications (NDAs). The Hatch-Waxman Amendments provided incentives and exclusivity to new drug entities. The agency states in the guidance that the current system is founded on the FDA’s interpretation of the word “drug.”
The FD&C Act defined “drug” broadly, leaving it to the FDA to interpret and apply the definition. A drug can be an ingredient or a finished product. The agency has recognized that could mean a drug substance or a drug product, and federal courts have agreed with these definitions. For marketing exclusivity rights, the FDA’s position has been that eligible drugs are drug products and not drug substances. Confirming its position, the FDA wrote a letter to the pharmaceutical industry in 1988 stating that a drug product is eligible for the five-year exclusivity period if it contains no active moiety that was previously approved by the Agency.
Re-Interpretation
To clarify and to move with the times, the agency says it will re-interpret drug to mean a drug substance, allowing the FDA to approve fixed-combination products as new and therefore eligible for 5 years of exclusivity. The FDA says that the previous approach to combination products is suboptimal as fixed-combinations are becoming more important in some diseases like cancer, cardiovascular disease, and infectious diseases. Additionally, combination products may offer better outcomes, less resistance, and lower rates of adverse events.
Draft Guidance
The draft guidance was published to elicit comments from industry, consumers, and medical professionals. The comment period is open until April 25, 2014. At the conclusion of the comment period, the FDA will evaluate comments and adjust the new rules as necessary before issuing final guidance.